BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALINIQ AMS

    MDR report key: 23233070 · Received October 7, 2025

    Report

    Report Number
    3004032053-2025-00019
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    September 23, 2025
    Report Date
    October 29, 2025
    Manufacturer
    ABBOTT SRL
    Product Code
    JQP
    UDI-DI
    00380740189914
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ISSUE AROSE WHEN A CUSTOMER REQUESTED AN ASSAY CODE CHANGE. THE UPDATE WAS CARRIED OUT USING THE INSTRUMENT CONFIGURATION INTERFACE, WHICH IS SORTED BY CHANNEL. DURING THE UPDATE, AN ADJACENT CHANNEL WAS UNINTENTIONALLY MODIFIED DUE TO THE ASSAYS HAVING CONSECUTIVE NUMBERS. THIS OCCURRED ONLY ON THAT SPECIFIC ALINITY INSTRUMENT AND WAS PERFORMED BY ABBOTT SERVICE PERSONNEL. THE MODIFICATION OF AN EXTRA CHANNEL LED TO INCORRECT TEST RESULT MAPPING AND CAUSED THE AMS TO ASSIGN A LACTATE RESULT TO A COCAINE TEST FIELD. A DATABASE QUERY CONFIRMED THAT ONLY ONE SAMPLE HAD BEEN REPORTED WITH THE INCORRECT ASSAY NUMBER ON THAT INSTRUMENT. TO RESOLVE THIS ISSUE, THE ASSAY NUMBER WAS PROMPTLY CORRECTED, FOLLOWED BY A SERVICE RESTART TO ENSURE THE CONFIGURATION UPDATE WAS EFFECTIVE. ADDITIONALLY, THE CUSTOMER WAS EDUCATED ON HOW TO VERIFY ASSAY NUMBERS IN THE CONFIGURATOR TO CONFIRM CHANGES AFTER FUTURE REQUESTS. A REVIEW OF THE LABELING ADDRESSES THE CUSTOMER¿S ISSUE AND CONFIRMED THAT LABELLING IS NOT RELATED, NOR CONTRIBUTING TO THE ISSUE IDENTIFIED IN THE CURRENT COMPLAINT. A 12-MONTH REVIEW OF SIMILAR COMPLAINTS DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY RELATED TO THE COMPLAINT ISSUE. A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY NONCONFORMANCES, POTENTIAL NONCONFORMANCE OR DEVIATIONS ASSOCIATED WITH THE CURRENT COMPLAINT ISSUE. BASED ON THE AVAILABLE INFORMATION NO DEFICIENCY RELATED TO THE CURRENT COMPLAINT ISSUE WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE ALINIQ AMS ASSIGNED A RESULT GENERATED FROM THE ALINITY TO AN INCORRECT PATIENT SAMPLE (40-YEAR-OLD FEMALE, SID (B)(6). A URINE SAMPLE HAD A DRUG SCREEN AND CREATININE TESTS ORDERED ON IT. IN THE ALINIQ AMS A COCAINE RESULT OF <0.19 WAS SHOWING FOR THE SAMPLE. HOWEVER, THE COCAINE REAGENT WASN¿T LOADED ON THE INSTRUMENT. UPON REVIEW, THE INSTRUMENT RAN A LACTATE TEST ON AN UNREQUESTED URINE SAMPLE, AND THE RESULT WAS ERRONEOUSLY LINKED TO THE COCAINE TEST ON THE ALINIQ AMS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE ALINIQ AMS ASSIGNED A RESULT GENERATED FROM THE ALINITY TO AN INCORRECT PATIENT SAMPLE (40 YEAR OLD FEMALE, (B)(6). A URINE SAMPLE HAD A DRUG SCREEN AND CREATININE TESTS ORDERED ON IT. IN THE ALINIQ AMS A COCAINE RESULT OF <0.19 WAS SHOWING FOR THE SAMPLE. HOWEVER, THE COCAINE REAGENT WASN¿T LOADED ON THE INSTRUMENT. UPON REVIEW, THE INSTRUMENT RAN A LACTATE TEST ON AN UNREQUESTED URINE SAMPLE, AND THE RESULT WAS ERRONEOUSLY LINKED TO THE COCAINE TEST ON THE ALINIQ AMS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2653900 ALINIQ AMS CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE JQP ABBOTT SRL 2.12 00380740189914

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female